Leads for electrostimulation of peripheral nerves and other targets

ABSTRACT

An electrical stimulation lead includes at least one lead body having a distal end portion, a proximal end portion, and a longitudinal length. The lead further includes a paddle body extending from the distal end portion of the at least one lead body, electrodes disposed along the paddle body, terminals disposed along the proximal end portion of the at least one lead body, and conductors electrically coupling the terminals to the electrodes. The lead further includes an anchoring device threadably disposed in at least a portion of the paddle body. The anchoring device has a head element and a tissue-engagement element fixed to the head element such that actuation of the head element urges the tissue-engagement element away from or toward the paddle body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application Ser. No. 62/344,839, filed Jun. 2, 2016,which is incorporated herein by reference.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making, using and implanting thesame. More specifically, the present invention is directed to systemsand methods for leads that provide electrostimulation to peripheralnerves and other target tissues, as well as methods of making, using andimplanting the leads and electrical stimulation systems.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat chronic pain syndrome and incontinence, with a number of otherapplications under investigation. Functional electrical stimulationsystems have been applied to restore some functionality to paralyzedextremities in spinal cord injury patients. Stimulation of the brain,such as deep brain stimulation, can be used to treat a variety ofdiseases or disorders.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

BRIEF SUMMARY

One embodiment is an electrical stimulation lead that includes at leastone lead body having a distal end portion, a proximal end portion, and alongitudinal length. The lead further includes a paddle body extendingfrom the distal end portion of the at least one lead body, electrodesdisposed along the paddle body, terminals disposed along the proximalend portion of the at least one lead body, and conductors electricallycoupling the terminals to the electrodes. The lead further includes ananchoring device threadably disposed in at least a portion of the paddlebody. The anchoring device has a head element and a tissue-engagementelement fixed to the head element such that actuation of the headelement urges the tissue-engagement element away from or toward thepaddle body.

In at least some embodiments, the paddle body includes a protuberanceextending from a remainder of the paddle body and at least a portion ofthe anchoring device is disposed in the protuberance. In at least someembodiments, the head element includes a recessed region configured tobe engaged by a tool. The recessed region can be hexagonally.

In at least some embodiments, the lead includes at least one additionalanchoring device threadably disposed in a different portion of thepaddle body.

In at least some embodiments, the tissue-engagement element is a helicalmember. The anchoring device is disposed along a side portion of thepaddle body, the anchoring device is disposed along an end portion ofthe paddle body, or some combination thereof.

In at least some embodiments, the paddle body includes a curved sectionlocated between the anchoring device and at least one additionalanchoring devices. The curved section is configured for placement over atarget tissue.

Another embodiment is an electrical stimulation lead for stimulating atarget tissue that includes a lead body having a distal end portion, aproximal end portion, and a longitudinal length, electrodes disposedalong the distal end portion of the lead body, terminals disposed alongthe proximal end portion of the lead body, and conductors electricallycoupling the terminals to the electrodes. The distal end of the leadbody includes a helical shape that variably locates the electrodesaround the target tissue in both a longitudinal and circumferentialdirection.

In at least some embodiments, the lead includes a stylet extendingthrough at least the distal end of the lead body. The stylet can behelically shaped nitinol wire.

In at least some embodiments, the distal end of the lead body is moldedinto the helical shape.

In at least some embodiments, the lead includes a sheath located over atleast a section of the distal end portion of the lead body. And, thesheath may include a slit for sliding the sheath over the lead body andthe target tissue.

A further embodiment is a method of implanting an electrical stimulationlead that includes the steps of (1) moving a distal end portion of thelead described above to be within a vicinity of a target tissue; (2)from a proximal end portion of the lead, inserting a styletlongitudinally into the lead, where a distal end portion of the styletincludes a helical shape; and (3) manipulating the stylet to urge thedistal end portion of the lead to helically wrap around the targettissue. Inserting the stylet may include inserting a nitinol guidewire.

Yet another embodiment is an electrical stimulation lead that includesat least one lead body having a distal end portion, a proximal endportion, and a longitudinal length, a paddle body extending from thedistal end portion of the at least one lead body, electrodes disposedalong the paddle body, terminals disposed along the proximal end portionof the at least one lead body, and conductors electrically coupling theterminals to the electrodes. The lead further includes an anchoringelement manipulatable to extend through at least a portion of the paddlebody. The anchoring element has a distal end portion adaptable to becomea tissue-engaging element when the distal end portion is urged out ofthe paddle body.

A further embodiment is an electrical stimulation system that includesany of the leads described above and a control module coupleable to thelead. The control module includes a housing and an electronicsubassembly disposed in the housing. The lead further includes aconnector for receiving the electrical stimulation lead, the connectorhaving a proximal end, a distal end, and a longitudinal length. Theconnector includes a connector housing defining a port at the distal endportion of the connector. The port is configured and arranged forreceiving the proximal end portion of the lead body of the electricalstimulation lead. The connecter further includes connector contactsdisposed in the connector housing. The connector contacts are configuredand arranged to couple to at least one of the terminals disposed on theproximal end portion of the lead body of the lead. In at least someembodiments, the lead includes a lead extension coupleable to both thelead and the control module.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system that includes a paddle lead electrically coupled to acontrol module, according to the invention;

FIG. 2 is a schematic view of one embodiment of an electricalstimulation system that includes a percutaneous lead electricallycoupled to a control module, according to the invention;

FIG. 3A is a schematic view of one embodiment of the control module ofFIG. 1 configured and arranged to electrically couple to an elongateddevice, according to the invention;

FIG. 3B is a schematic view of one embodiment of a lead extensionconfigured and arranged to electrically couple the elongated device ofFIG. 2 to the control module of FIG. 1, according to the invention;

FIG. 4A is a schematic, perspective view of a paddle-style lead having aplurality of anchoring devices according to an embodiment of the presentinvention;

FIG. 4B is a plan view of the paddle-style lead of FIG. 4A;

FIG. 4C is a side elevational view of the paddle-style lead of FIG. 4A;

FIG. 5 is a schematic, plan view of another paddle-style lead having aplurality of anchoring devices according to another embodiment of thepresent invention;

FIG. 6A is a schematic, perspective view of a curved paddle-style leadhaving a plurality of anchoring devices according to an embodiment ofthe present invention;

FIG. 6B is a close-up view of at least one of the anchoring devices ofthe curved paddle-style lead of FIG. 6A;

FIG. 6C is an end view of the curved paddle-style lead of FIG. 6A;

FIG. 7 is a schematic, perspective view of a helical lead according toan embodiment of the present invention;

FIG. 8A is a schematic, perspective view of a paddle-style lead havingdeployable and retractable tissue-engagement devices according to anembodiment of the present invention;

FIG. 8B is a close-up view of a tissue-engagement device retracted in alumen according to an embodiment of the present invention;

FIG. 8C is a close-up view of the tissue-engagement device of FIG. 8Bextending from the lumen according to an embodiment of the presentinvention;

FIG. 9A is a schematic, perspective view of a sheath covering at least aportion of a helical lead according to an embodiment of the presentinvention;

FIG. 9B is a schematic, perspective view of a sheath for the helicallead of FIG. 9A according to an embodiment of the present invention;

FIG. 9C is a schematic, perspective view of another sheath for thehelical lead of FIG. 9A according to another embodiment of the presentinvention;

FIG. 9D is a schematic, perspective view of yet another sheath for thehelical lead of FIG. 9A according to yet another embodiment of thepresent invention; and

FIG. 10 is a schematic diagram of an electrical stimulation systemaccording to an embodiment of the present invention.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making, using and implanting thesame. More specifically, the present invention is directed to systemsand methods for leads that provide electrostimulation to targets such asperipheral nerves, as well as methods of making, using and implantingthe leads and electrical stimulation systems.

Suitable implantable electrical stimulation systems include, but are notlimited to, a least one lead with one or more electrodes disposed alonga distal end of the lead. Leads include, for example, percutaneousleads, paddle leads, and cuff leads. Examples of electrical stimulationsystems with leads are found in, for example, U.S. Pat. Nos. 6,181,969;6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,203,548; 7,244,150;7,450,997; 7,596,414; 7,610,103; 7,672,734; 7,761,165; 7,783,359;7,792,590; 7,809,446; 7,949,395; 7,974,706; 6,175,710; 6,224,450;6,271,094; 6,295,944; 6,364,278; and 6,391,985; U.S. Patent ApplicationsPublication Nos. 2007/0150036; 2009/0187222; 2009/0276021; 2010/0076535;2010/0268298; 2011/0004267; 2011/0078900; 2011/0130817; 2011/0130818;2011/0238129; 2011/0313500; 2012/0016378; 2012/0046710; 2012/0071949;2012/0165911; 2012/0197375; 2012/0203316; 2012/0203320; 2012/0203321;2012/0316615; and 2013/0105071; and U.S. patent application Ser. Nos.12/177,823 and 13/750,725, all of which are incorporated by reference intheir entireties. Examples of implanting or anchoring leads may be foundin U.S. Pat. Nos. 8,019,443; 8,718,790; 8,768,488; 8,849,422; and U.S.Patent Publication Nos. 2012/0185027; 2013/01317518, which areincorporated by reference in their entireties.

FIG. 1 illustrates schematically one embodiment of an electricalstimulation system 100. The electrical stimulation system includes acontrol module (e.g., a stimulator or pulse generator) 102 and a lead103 coupleable to the control module 102. The lead 103 includes a paddlebody 104 and one or more lead bodies 106. In FIG. 1, the lead 103 isshown having two lead bodies 106. It will be understood that the lead103 can include any suitable number of lead bodies including, forexample, one, two, three, four, five, six, seven, eight or more leadbodies 106. An array 133 of electrodes, such as electrode 134, isdisposed on the paddle body 104, and an array of terminals (e.g., 310 inFIG. 3A-3B) is disposed along each of the one or more lead bodies 106.

It will be understood that the electrical stimulation system can includemore, fewer, or different components and can have a variety of differentconfigurations including those configurations disclosed in theelectrical stimulation system references cited herein. For example,instead of a paddle body, the electrodes can be disposed in an array ator near the distal end of a lead body forming a percutaneous lead.

FIG. 2 illustrates schematically another embodiment of the electricalstimulation system 100, where the lead 103 is a percutaneous lead. InFIG. 2, the electrodes 134 are shown disposed along the one or more leadbodies 106. In at least some embodiments, the lead 103 is isodiametricalong a longitudinal length of the lead body 106.

The lead 103 can be coupled to the control module 102 in any suitablemanner. In FIG. 1, the lead 103 is shown coupling directly to thecontrol module 102. In at least some other embodiments, the lead 103couples to the control module 102 via one or more intermediate devices(324 in FIG. 3B). For example, in at least some embodiments one or morelead extensions 324 (see e.g., FIG. 3B) can be disposed between the lead103 and the control module 102 to extend the distance between the lead103 and the control module 102. Other intermediate devices may be usedin addition to, or in lieu of, one or more lead extensions including,for example, a splitter, an adaptor, or the like or combinationsthereof. It will be understood that, in the case where the electricalstimulation system 100 includes multiple elongated devices disposedbetween the lead 103 and the control module 102, the intermediatedevices may be configured into any suitable arrangement.

In FIG. 2, the electrical stimulation system 100 is shown having asplitter 107 configured and arranged for facilitating coupling of thelead 103 to the control module 102. The splitter 107 includes a splitterconnector 108 configured to couple to a proximal end of the lead 103,and one or more splitter tails 109 a and 109 b configured and arrangedto couple to the control module 102 (or another splitter, a leadextension, an adaptor, or the like).

With reference to FIGS. 1 and 2, the control module 102 typicallyincludes a connector housing 112 and a sealed electronics housing 114.An electronic subassembly 110 and an optional power source 120 aredisposed in the electronics housing 114. A control module connector 144is disposed in the connector housing 112. The control module connector144 is configured and arranged to make an electrical connection betweenthe lead 103 and the electronic subassembly 110 of the control module102.

The electrical stimulation system or components of the electricalstimulation system, including the paddle body 104, the one or more ofthe lead bodies 106, and the control module 102, are typically implantedinto the body of a patient. The electrical stimulation system can beused for a variety of applications including, but not limited to deepbrain stimulation, neural stimulation, spinal cord stimulation, musclestimulation, and the like.

The electrodes 134 can be formed using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. In at least some embodiments, one or more of theelectrodes 134 are formed from one or more of: platinum, platinumiridium, palladium, palladium rhodium, or titanium.

Any suitable number of electrodes 134 can be disposed on the leadincluding, for example, four, five, six, seven, eight, nine, ten,eleven, twelve, fourteen, sixteen, twenty-four, thirty-two, or moreelectrodes 134. In the case of paddle leads, the electrodes 134 can bedisposed on the paddle body 104 in any suitable arrangement. In FIG. 1,the electrodes 134 are arranged into two columns, where each column haseight electrodes 134.

The electrodes of the paddle body 104 (or one or more lead bodies 106)are typically disposed in, or separated by, a non-conductive,biocompatible material such as, for example, silicone, polyurethane,polyetheretherketone (“PEEK”), epoxy, and the like or combinationsthereof. The one or more lead bodies 106 and, if applicable, the paddlebody 104 may be formed in the desired shape by any process including,for example, molding (including injection molding), casting, and thelike. The non-conductive material typically extends from the distal endsof the one or more lead bodies 106 to the proximal end of each of theone or more lead bodies 106.

In the case of paddle leads, the non-conductive material typicallyextends from the paddle body 104 to the proximal end of each of the oneor more lead bodies 106. Additionally, the non-conductive, biocompatiblematerial of the paddle body 104 and the one or more lead bodies 106 maybe the same or different. Moreover, the paddle body 104 and the one ormore lead bodies 106 may be a unitary structure or can be formed as twoseparate structures that are permanently or detachably coupled together.

Terminals (e.g., 310 in FIGS. 3A-3B) are typically disposed along theproximal end of the one or more lead bodies 106 of the electricalstimulation system 100 (as well as any splitters, lead extensions,adaptors, or the like) for electrical connection to correspondingconnector contacts (e.g., 314 in FIG. 3A). The connector contacts aredisposed in connectors (e.g., 144 in FIGS. 1-3B; and 322 FIG. 3B) which,in turn, are disposed on, for example, the control module 102 (or a leadextension, a splitter, an adaptor, or the like). Electrically conductivewires, cables, or the like (not shown) extend from the terminals to theelectrodes 134. Typically, one or more electrodes 134 are electricallycoupled to each terminal. In at least some embodiments, each terminal isonly connected to one electrode 134.

The electrically conductive wires (“conductors”) may be embedded in thenon-conductive material of the lead body 106 or can be disposed in oneor more lumens (not shown) extending along the lead body 106. In someembodiments, there is an individual lumen for each conductor. In otherembodiments, two or more conductors extend through a lumen. There mayalso be one or more lumens (not shown) that open at, or near, theproximal end of the one or more lead bodies 106, for example, forinserting a stylet to facilitate placement of the one or more leadbodies 106 within a body of a patient. Additionally, there may be one ormore lumens (not shown) that open at, or near, the distal end of the oneor more lead bodies 106, for example, for infusion of drugs ormedication into the site of implantation of the one or more lead bodies106. In at least one embodiment, the one or more lumens are flushedcontinually, or on a regular basis, with saline, epidural fluid, or thelike. In at least some embodiments, the one or more lumens arepermanently or removably sealable at the distal end.

FIG. 3A is a schematic side view of one embodiment of a proximal end ofone or more elongated devices 300 configured and arranged for couplingto one embodiment of the control module connector 144. The one or moreelongated devices may include, for example, one or more of the leadbodies 106 of FIG. 1, one or more intermediate devices (e.g., asplitter, the lead extension 324 of FIG. 3B, an adaptor, or the like orcombinations thereof), or a combination thereof.

The control module connector 144 defines at least one port into which aproximal end of the elongated device 300 can be inserted, as shown bydirectional arrows 312 a and 312 b. In FIG. 3A (and in other figures),the connector housing 112 is shown having two ports 304 a and 304 b. Theconnector housing 112 can define any suitable number of ports including,for example, one, two, three, four, five, six, seven, eight, or moreports.

The control module connector 144 also includes a plurality of connectorcontacts, such as connector contact 314, disposed within each port 304 aand 304 b. When the elongated device 300 is inserted into the ports 304a and 304 b, the connector contacts 314 can be aligned with a pluralityof terminals 310 disposed along the proximal end(s) of the elongateddevice(s) 300 to electrically couple the control module 102 to theelectrodes (134 of FIG. 1) disposed on the paddle body 104 of the lead103. Examples of connectors in control modules are found in, forexample, U.S. Pat. Nos. 7,244,150 and 8,224,450, which are incorporatedby reference.

FIG. 3B is a schematic side view of another embodiment of the electricalstimulation system 100. The electrical stimulation system 100 includes alead extension 324 that is configured and arranged to couple one or moreelongated devices 300 (e.g., one of the lead bodies 106 of FIGS. 1 and2, the splitter 107 of FIG. 2, an adaptor, another lead extension, orthe like or combinations thereof) to the control module 102. In FIG. 3B,the lead extension 324 is shown coupled to a single port 304 defined inthe control module connector 144. Additionally, the lead extension 324is shown configured and arranged to couple to a single elongated device300. In alternate embodiments, the lead extension 324 is configured andarranged to couple to multiple ports 304 defined in the control moduleconnector 144, or to receive multiple elongated devices 300, or both.

A lead extension connector 322 is disposed on the lead extension 324. InFIG. 3B, the lead extension connector 322 is shown disposed at a distalend 326 of the lead extension 324. The lead extension connector 322includes a connector housing 328. The connector housing 328 defines atleast one port 330 into which terminals 310 of the elongated device 300can be inserted, as shown by directional arrow 338. The connectorhousing 328 also includes a plurality of connector contacts, such asconnector contacts 340. When the elongated device 300 is inserted intothe port 330, the connector contacts 340 disposed in the connectorhousing 328 can be aligned with the terminals 310 of the elongateddevice 300 to electrically couple the lead extension 324 to theelectrodes (134 of FIGS. 1 and 2) disposed along the lead (103 in FIGS.1 and 2).

In at least some embodiments, the proximal end of the lead extension 324is similarly configured and arranged as a proximal end of the lead 103(or other elongated device 300). The lead extension 324 may include aplurality of electrically conductive wires (not shown) that electricallycouple the connector contacts 340 to a proximal end 348 of the leadextension 324 that is opposite to the distal end 326. In at least someembodiments, the conductive wires disposed in the lead extension 324 canbe electrically coupled to a plurality of terminals (not shown) disposedalong the proximal end 348 of the lead extension 324. In at least someembodiments, the proximal end 348 of the lead extension 324 isconfigured and arranged for insertion into a connector disposed inanother lead extension (or another intermediate device). In otherembodiments (and as shown in FIG. 3B), the proximal end 348 of the leadextension 324 is configured and arranged for insertion into the controlmodule connector 144.

The following embodiments of the present invention describe apaddle-style lead, a helical lead, or some combination of both. One orboth of the leads can be used for any type of electrostimulation (e.g.,neurostimulation, neuromodulation or some other type ofelectrostimulation). For example, the lead can be used for stimulationof a target tissue such as a target nerve or target organ, and morespecifically such as peripheral targets that may include, but are notlimited to, peripheral nerves, the sympathetic chain/trunk, the adrenalgland, and other nerves or stimulation targets that may be rather closeto a surface of a patient's skin. In at least some embodiments, one orboth leads may be implanted in unconstrained environments, so theembodiments described herein provide structures and methods to secure oranchor the leads to the patient's tissue in a vicinity of the targettissue. The paddle-style lead employs active or positivetissue-engagement elements or devices while the helical lead employs ashape and implantation method that permits the helical lead to bewrapped or coiled around the target. In at least some embodiments, thetissue-engagement elements or devices provide for dimensional stabilityalong a longitudinal axis and a lateral axis of the paddle-style lead.The following embodiments may be combined with any of the aspects orfeatures of the aforementioned embodiments.

FIG. 4A is a schematic, perspective view of a paddle-style lead 400 andFIG. 4B is a top, plan view of the paddle-style lead 400. In at leastsome embodiments, the paddle-style lead 400 includes a paddle body 402,a plurality of electrodes 404 disposed along and within the paddle body402, and at least one lead body 406 extending from the paddle body 402.In the illustrated embodiment, the paddle body 402 includes a pluralityof protuberances 408 extending laterally from the paddle body 402 (but,see FIG. 5 and the respective description thereof for protuberancesextending from different portions of the paddle body). The protuberances408 take the form of a half-circle, but may take a variety of othershapes having a variety of contours such as, but not limited to, bevelededges or rounded edges.

As described above with respect to FIG. 1, any suitable number ofelectrodes 404 can be disposed on the paddle-style lead including, forexample, four, five, six, seven, eight, nine, ten, eleven, twelve,fourteen, sixteen, twenty-four, thirty-two, or more electrodes 404. InFIGS. 4A and 4B, the electrodes 404 are arranged into two columns, whereeach column has five electrodes 404. In at least some embodiments, theelectrodes 404 can be disposed within or mechanically coupled to thepaddle body 402 using, for example, an overmolding process, a mechanicalbonding process, or a chemical bonding process. When chemically bonded,a primer layer may be applied to the electrodes 404 before any moldingor bonding.

The electrodes 404 can be made from any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. In at least some embodiments, one or more of theelectrodes 404 are formed from one or more of: platinum, platinumiridium, palladium, palladium rhodium, titanium, stainless steel, or anyother suitable biocompatible conductive material (e.g., a conductivepolymer). Additionally or alternatively, the electrodes 404 may becoated with a second conductive material that exhibits preferredchemical, electrochemical, or physical properties such as, but notlimited to, iridium, iridium oxide, or titanium nitride.

The paddle body 402 can be made from a non-conductive, biocompatiblematerial such as, for example, silicone, polyurethanes (PU),polyetheretherketone (“PEEK”), polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), polyisobutylene polyurethane (PIB-PUR), poly(styrene-block-isobutylene-block-styrene) (SIBS), epoxy, any othersuitable biocompatible material, and any combinations thereof.Additionally or alternatively and with respect to the paddle body 402,the lead body 406, the protuberances 408, or both may be made fromsimilar materials, a similar combination or a different material ormaterials as the paddle body 402.

FIG. 4C shows a side, elevational view of the paddle-style lead 400 ofFIGS. 4A and 4B. In the illustrated embodiment, the paddle body 402takes the form or a flat or planar paddle-style body (but, see FIGS.6A-6C and the respective description thereof for a curved-type paddlebody). In the case of paddle-style leads, the electrodes 404 can bedisposed on the paddle body 402 in any suitable arrangement. The paddlebody 402 includes a first surface 410 and an opposing surface 412. Theelectrodes 404 are flush with one of the surfaces 410 or 412. In theillustrated embodiment, the electrodes 404 are flush with the opposingsurface 412.

The paddle-style lead 400 further includes one or more anchoring devices414. Each anchoring device includes a head element 416 coupled to atissue-engagement element 418. In the illustrated embodiment, theanchoring device 414 extends through both the paddle body 402 and theprotuberance 408. In other embodiments, the anchoring device 414 mayextend only through the paddle body 402 or may extend only through theprotuberance 408. The head element 416 may take the form of a fastenerhead having a recess portion, described in more detail with respect toFIG. 6B, configured to receive or engage with a tool. Thetissue-engagement element 418 may take the form of an active or positivehelical member. The terms “active” and “positive” generally mean thatthe tissue-engagement elements 418 are urged into the patient's tissueas contrasted with a passive anchoring system such as, for example,holes extending through the paddle body that permit the ingrowth oftissue over time to reduce or prevent undesired lead migration.

In at least some embodiments, the head element 416 and thetissue-engagement element 418 are made from stainless steel. However,these elements 416, 418 can be made from a different material such asmaterials used for the electrodes or other materials such as MP35N,titanium, rigid plastics or the like. Additionally or alternatively, thehead element 416 can made from a different material than thetissue-engagement element 418 or vice-versa.

In at least some embodiments, the paddle-style lead 400 includes two ormore tissue-engagement elements 418 that are each contained within thepaddle body 402 prior to implantation. The two or more tissue-engagementelements may be configured such that they are not able to fullydisengage from the paddle (e.g., not able to back out completely), suchthat it is not possible for the engagement element to become “lost” in apatient.

Additionally or alternatively, the head element may be protected with aplug or septum, such as a slit polymer plug or a silicone seal plug,that keeps tissue from growing in and around the head element. The plugmay be similar to the plugs that are used in many pulse generatorheaders around set screws that engage a lead terminal.

The illustrated embodiment of FIGS. 4A-4C has four tissue-engagementelements. Once the paddle-style lead 400 is positioned in a selectedlocation within the patient during implantation, then a tool (not shown)is used to engage the head element 416 and rotate the head element 416until the tissue-engagement element 418 has been extended out of thepaddle body 402 and into the patient's tissue by an amount that may bedetermined during, or prior to, implantation and may differ betweenpatients, situations or because of other factors. In at least someembodiments, the tissue-engagement elements 418 extend from the surfaceof the paddle body 402 that is flush with the electrodes, which would bethe opposing surface 412 in the illustrated embodiment. Thetissue-engagement elements 418 may have different configurationsdepending on the type of tissue to be engaged. In the illustratedembodiment, the tissue-engagement elements 418 are configured with ahelical configuration for insertion into the fascia of underlyingmuscle, into the peritoneum, or into other connective tissue within avicinity of a target such as a peripheral target. In at least someembodiments, the paddle-style lead 400 can be delivered into the patientthrough a laparoscopic procedure or through open access procedure. In atleast some embodiments, the paddle body 402 may include any number oranchoring devices 414, but preferably at least two anchoring devices.Additionally or alternatively, the anchoring devices can be arrangedrelative to the paddle body in a variety of ways, for example such asthe illustrated embodiment in which the anchoring devices 414 arelocated adjacent to side portions of the paddle body 402.

FIG. 5 shows a top, plan view of a paddle-style lead 500. In at leastsome embodiments, the paddle-style lead 500 includes a paddle body 502,a plurality of electrodes 504 disposed along and within the paddle body502, and at least one lead body 506 extending from the paddle body 502.In the illustrated embodiment, the paddle body 502 includes a pluralityof protuberances 508 extending from end portions of the paddle body 502,as contrasted to extending laterally as shown in FIG. 4B. Again, theprotuberances 508 can have the shape or configuration of a half-circle,but may take a variety of other shapes having a variety of contours suchas, but not limited to, beveled edges or rounded edges. Theprotuberances 508 can be integrally formed with the paddle body 502 ormechanically coupled to the paddle body 502. In at least someembodiments, the paddle body 402 may include any number or protuberances508, but preferably at least two protuberances. Additionally oralternatively, the protuberances can be arranged relative to the paddlebody in a variety of ways, for example such as the illustratedembodiment in which the protuberances 508 are located adjacent to endportions of the paddle body 502.

FIG. 6A shows a schematic, perspective view of a paddle-style lead 600having a curved paddle body 602. FIG. 6B shows a close-up view of one ofthe anchoring devices of the paddle-style lead 600. And, FIG. 6C showsan end view of the paddle-style lead 600 with the anchoring devicesactuated or at least partially actuated. In at least some embodiments, aplurality of electrodes 604 are disposed within the curved paddle body602 and flush with a concave surface of the curved paddle body 602.Similar to the paddle-style lead 400 described above, the paddle-stylelead 600 includes protuberances 608 that are arranged relative to thecurved paddle body 602. In at least some embodiments, the curved sectionof the paddle body 602 is located between the anchoring devices,protuberances or both. Additionally or alternatively, the curved sectionis configured for placement over a target such as, but not limited to, aperipheral nerve.

In at least some embodiments, the curved paddle body 602 may be tailoredfor a specific tissue, nerve or organ size, or in some cases, betailored to be patient-specific to match an anatomy size found duringpre-operative imaging. While the illustrated, curved paddle body 602 isshown to be curved about the long axis, it is appreciated that thecurved paddle body may also be curved about the short axis (e.g., tocurve around an organ).

Referring to FIG. 6B, the paddle-style lead 600 includes anchoringdevices 614 each having a head element 616 coupled to atissue-engagement element 618. In the illustrated embodiment, eachanchoring device 614 extends through both the curved paddle body 602 oneof the respective protuberances 608. In at least some other embodiments,the anchoring device 614 may extend only through the paddle body 602 ormay extend only through the protuberance 608.

The head element 616 may take the form of a socket head or hex sockethaving a recessed portion 620 configured to receive or engage with atool (not shown). In the illustrated embodiment, the head elementcomprises a recessed portion 620 having a hexagonal configuration forreceiving tool, which may take the form of a hex key, hex wrench orAllen wrench. In at least some other embodiments, the head element 616may have a different configuration for engagement with a different typeof torque-application tool. By way of example, the head element may takethe form of a flathead, Philips, square, or star-shape pattern.

Referring to FIG. 6C, the tissue-engagement element 618 is a spiraling,helical rod threadably coupled to the head element 616. The helical rodmay vary in diameter, pitch and pitch angle over a length of the helicalrod. Additionally or alternatively, each anchor device 614 of a singlepaddle-style lead 600 may each have its own configuration depending onthe local tissue to be engaged. In other embodiments, thetissue-engagement element may be an externally threaded rod that extendsfrom the paddle body. In yet other embodiments, a single anchoringdevice 614 may include more than one tissue-engagement element 618.

FIG. 7 is a schematic, plan, exploded view of a distal end portion of ahelical lead 700 for electrostimulation of a target tissue 701, whichaccording to at least some embodiments may take the form of a peripheralnerve. In at least some embodiments, the helical lead 700 includes alead body 702, a plurality of electrodes 704 (e.g., circumferential orsegmented electrodes), and a lumen 706 configured to receive a guidewireor stylet 708. The helical lead 700 operates to wrap around the targettissue 701 to reduce lead migration and to provide more effectiveelectrostimulation of the target tissue 701.

In at least some embodiments, inserting the stylet 708 causes the distalend portion of the lead 700 to have a helical shape. It will beunderstood that the lead can be bent into other shapes using the stylet708. In at least some embodiments, the stylet 708 is inserted throughthe lumen 706 that extends along at least a portion of the leadincluding, preferably, the distal end portion of the lead 700. It willalso be understood that more than one guidewire or stylet can be usedand may be inserted into the same lumen or different lumens within thelead. In at least some embodiment, the stylet 708 may have an amount ofstiffness that allows it to be delivered along the target tissue 701 byrotating the lead 700 with the stylet 708 inserted such that the lead700 is forced to “corkscrew” around the target tissue 701. In at leastsome embodiments, the stylet 708 is made from nitinol, but it isappreciated that other materials may be used for the stylet.

In at least some embodiments, the lead body 702 may be molded to have aloose helical shape before insertion or retraction of the stylet 708while the stylet 708 is straight when inserted into the lumen 706.Insertion of the stylet 708 causes the lead 700 to straighten andremoval of the stylet 708 causes the lead 700 to take on the helicalshape or twist. In at least some other embodiments, the stylet 708 has ahelical shape and causes a straight lead to take on the helical shapebefore insertion into or after retraction of the stylet 708 from thelumen 706.

In at least some embodiments, the stylet 708 may remain in the lead 700after implantation to retain the helical or other shape of the distalend of the lead 700. In other embodiments, the stylet 708 may be removedafter implantation and the distal end of the lead 700 is arranged tomaintain the helical or other shape on its own.

FIG. 8A shows a schematic view of a paddle-style lead 800 having apaddle body 802 and a manipulatable paddle fixation system 804. FIGS. 8Band 8C show schematic, close-up views of the paddle fixation system 804during deployment. In at least some embodiments, one or moretissue-engagement devices may be deployed from the paddle body 802 atvarious locations, for example from any of the distal, proximal,lateral, top and bottom surfaces of the paddle body 802. In theillustrated embodiment, first tissue-engagement devices 806 extend fromthe distal surface 808 of the paddle body 802 and a secondtissue-engagement device 810 extends from a lateral surface 812 of thepaddle body 802. In at least some embodiments, the firsttissue-engagement devices 806 have a hooked or curved shape while thesecond tissue-engagement device 810 has a spiral, coiled or helicalshape, however it is understood that the tissue-engagement devices 806,810 may take a variety of shapes. In at least some embodiments, thetissue-engagement devices 806, 810 are made from a shape memory materialsuch as, but not limited to, nitinol.

In at least some embodiments, deployment or retraction of thetissue-engagement devices 806, 810 may be accomplished by using a tool,such as forceps, to translate or otherwise urge the tissue-engagementdevices 806, 810 out of or back into the paddle body 802 as indicated byarrow 814. In other embodiments, a mechanism (not shown) coupled to aproximal end of the lead 800 may be used to deploy or retract thetissue-engagement devices 806, 810. The mechanism may be manipulated,rotated or otherwise actuated to cause the tissue-engagement devices806, 810 to deploy or retract from the paddle body 802.

FIG. 8B shows a close-up view of the tissue-engagement device 806 in aretracted position within a lumen 816. FIG. 8C shows a close-up view ofthe tissue-engagement device 806 in a deployed position relative to thelumen 816. In at least some embodiments, the lumen 816 extends throughthe paddle body 802.

FIG. 9A shows a schematic, perspective view of a helical lead 900 woundaround and along a target tissue 901 and covered, at least partially, bya sheath 910.

Similar to FIG. 7, the helical lead 900 includes a lead body 902, aplurality of electrodes 904 (e.g., circumferential or segmentedelectrodes), and a lumen 906 configured to receive a guidewire or stylet(not shown). In at least some embodiments, the sheath 910 functions asan insulator to reduce or prevent electrostimulation of surroundingtissue. Accordingly, the sheath 910 is made from an insulating material.

FIGS. 9B-9D show schematic, perspective views of several different typesof sheaths according to various embodiments of the invention. FIG. 9Bshows a sheath 910 a having a longitudinal slit 912 a that permits thesheath to be laterally slid or placed over the lead (e.g., generallyreferred to as “side loading”). FIG. 9C shows a sheath 910 b having aspiral or helical shaped slit 912 b that permits the sheath to bewrapped around the lead in a corkscrew or twisting manner. FIG. 9D showsa sheath 910 c having a longitudinal slit 912 c that allows the lead tobe received into a first channel 914 c. After the lead is positionedvis-à-vis the target tissue, the lead can be urged into a second channel916 c, which is smaller than the first channel 914 c and configured toengage with and retain the lead within the second channel 916 c.

FIG. 10 is a schematic overview of one embodiment of components of anelectrical stimulation arrangement 1080 that includes an electricalstimulation system 1082 with a lead 1084, stimulation circuitry 1086, apower source 1088, and an antenna 1090. The electrical stimulationsystem can be, for example, any of the electrical stimulation systemsdescribed above. It will be understood that the electrical stimulationarrangement can include more, fewer, or different components and canhave a variety of different configurations including thoseconfigurations disclosed in the stimulator references cited herein.

If the power source 1088 is a rechargeable battery or chargeablecapacitor, the power source may be recharged/charged using the antenna1090, if desired. Power can be provided for recharging/charging byinductively coupling the power source 1088 through the antenna 1090 to arecharging unit 1096 external to the user. Examples of such arrangementscan be found in the references identified above.

In one embodiment, electrical current is emitted by the electrodes (suchas electrodes 134 in FIG. 1) on the lead 1084 to stimulate nerve fibers,muscle fibers, or other body tissues near the electrical stimulationsystem. The stimulation circuitry 1086 can include, among othercomponents, a processor 1094 and a receiver 1092. The processor 1094 isgenerally included to control the timing and electrical characteristicsof the electrical stimulation system. For example, the processor 1094can, if desired, control one or more of the timing, frequency, strength,duration, and waveform of the pulses. In addition, the processor 1094can select which electrodes can be used to provide stimulation, ifdesired. In some embodiments, the processor 1094 selects whichelectrode(s) are cathodes and which electrode(s) are anodes. In someembodiments, the processor 1094 is used to identify which electrodesprovide the most useful stimulation of the desired tissue.

Any processor can be used and can be as simple as an electronic devicethat, for example, produces pulses at a regular interval or theprocessor can be capable of receiving and interpreting instructions froman external programming unit 1098 that, for example, allows modificationof pulse characteristics. In the illustrated embodiment, the processor1094 is coupled to a receiver 1092 which, in turn, is coupled to theantenna 1090. This allows the processor 1094 to receive instructionsfrom an external source to, for example, direct the pulsecharacteristics and the selection of electrodes, if desired.

In one embodiment, the antenna 1090 is capable of receiving signals(e.g., RF signals) from an external telemetry unit 1099 that isprogrammed by the programming unit 1098. The programming unit 1098 canbe external to, or part of, the telemetry unit 1099. The telemetry unit1099 can be a device that is worn on the skin of the user or can becarried by the user and can have a form similar to a pager, cellularphone, or remote control, if desired. As another alternative, thetelemetry unit 1099 may not be worn or carried by the user but may onlybe available at a home station or at a clinician's office. Theprogramming unit 1098 can be any unit that can provide information tothe telemetry unit 1099 for transmission to the electrical stimulationsystem 1082. The programming unit 1098 can be part of the telemetry unit1099 or can provide signals or information to the telemetry unit 1099via a wireless or wired connection. One example of a suitableprogramming unit is a computer operated by the user or clinician to sendsignals to the telemetry unit 1099.

The signals sent to the processor 1094 via the antenna 1090 and thereceiver 1092 can be used to modify or otherwise direct the operation ofthe electrical stimulation system 1082. For example, the signals may beused to modify the pulses of the electrical stimulation system such asmodifying one or more of pulse duration, pulse frequency, pulsewaveform, and pulse strength. The signals may also direct the electricalstimulation system 1082 to cease operation, to start operation, to startcharging the battery, or to stop charging the battery.

Optionally, the electrical stimulation system 1082 may include atransmitter (not shown) coupled to the processor 1094 and the antenna1090 for transmitting signals back to the telemetry unit 1099 or anotherunit capable of receiving the signals. For example, the electricalstimulation system 1082 may transmit signals indicating whether theelectrical stimulation system 1082 is operating properly or not orindicating when the battery needs to be charged or the level of chargeremaining in the battery. The processor 1094 may also be capable oftransmitting information about the pulse characteristics so that a useror clinician can determine or verify the characteristics.

The above specification provides a description of the structure,manufacture, and use of the invention. Since many embodiments of theinvention can be made without departing from the spirit and scope of theinvention, the invention also resides in the claims hereinafterappended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. An electrical stimulation lead comprising: atleast one lead body having a distal end portion, a proximal end portion,and a longitudinal length; a paddle body extending from the distal endportion of the at least one lead body; a plurality of electrodesdisposed along the paddle body; a plurality of terminals disposed alongthe proximal end portion of the at least one lead body; a plurality ofconductors electrically coupling the plurality of terminals to theplurality of electrodes; and an anchoring device threadably disposed inat least a portion of the paddle body, the anchoring device having ahead element and a tissue-engagement element fixed to the head element,wherein actuation of the head element urges the tissue-engagementelement away from or toward the paddle body.
 2. The lead of claim 1,wherein the paddle body includes a protuberance extending from aremainder of the paddle body, wherein at least a portion of theanchoring device is disposed in the protuberance.
 3. The lead of claim1, wherein the head element includes a recessed region configured to beengaged by a tool.
 4. The lead of claim 3, wherein the recessed regionis hexagonally shaped.
 5. The lead of claim 1, further comprising atleast one additional anchoring device threadably disposed in a differentportion of the paddle body.
 6. The lead of claim 1, wherein thetissue-engagement element is a helical member.
 7. The lead of claim 1,wherein the anchoring device is disposed along a side portion of thepaddle body.
 8. The lead of claim 1, wherein the anchoring device isdisposed along an end portion of the paddle body.
 9. The lead of claim1, wherein the paddle body includes a curved section located between theanchoring device and at least one additional anchoring devices, thecurved section configured for placement over a target tissue.
 10. Anelectrical stimulation system comprising: the electrical stimulationlead of claim 1; a control module coupleable to the electricalstimulation lead, the control module comprising a housing, and anelectronic subassembly disposed in the housing; and a connector forreceiving the electrical stimulation lead, the connector having aproximal end, a distal end, and a longitudinal length, the connectorcomprising a connector housing defining a port at the distal end portionof the connector, the port configured and arranged for receiving theproximal end portion of the lead body of the electrical stimulationlead, and a plurality of connector contacts disposed in the connectorhousing, the plurality of connector contacts configured and arranged tocouple to at least one of the plurality of terminals disposed on theproximal end portion of the lead body of the electrical stimulationlead.
 11. The electrical stimulation system of claim 10, furthercomprising a lead extension coupleable to both the electricalstimulation lead and the control module.
 12. An electrical stimulationlead for stimulating a target tissue, the lead comprising: a lead bodyhaving a distal end portion, a proximal end portion, and a longitudinallength; a plurality of electrodes disposed along the distal end portionof the lead body; a plurality of terminals disposed along the proximalend portion of the lead body; and a plurality of conductors electricallycoupling the plurality of terminals to the plurality of electrodes,wherein at least the distal end portion of the lead body includes ahelical shape that variably locates the plurality of electrodes aroundthe target tissue in both a longitudinal and circumferential direction.13. The lead of claim 12, further comprising a stylet extending throughat least the distal end portion of the lead body, wherein the stylet ishelically shaped.
 14. The lead of claim 13, wherein the stylet isnitinol wire.
 15. The lead of claim 12, wherein the distal end portionof the lead body is molded into the helical shape.
 16. The lead of claim12, further comprising a sheath located over at least a section of thedistal end portion of the lead body.
 17. The lead of claim 16, whereinthe sheath includes a slit for sliding the sheath over the lead body andthe target tissue.
 18. A method of implanting an electrical stimulationlead, the method comprising: moving a distal end portion of the lead ofclaim 12 to be within a vicinity of a target tissue; from a proximal endportion of the lead, inserting a stylet longitudinally into the lead,wherein a distal end portion of the stylet includes a helical shape; andmanipulating the stylet to urge the distal end portion of the lead tohelically wrap around the target tissue.
 19. The method of claim 18,wherein inserting the stylet includes inserting a nitinol guidewire. 20.An electrical stimulation lead comprising: at least one lead body havinga distal end portion, a proximal end portion, and a longitudinal length;a paddle body extending from the distal end portion of the at least onelead body; a plurality of electrodes disposed along the paddle body; aplurality of terminals disposed along the proximal end portion of the atleast one lead body; a plurality of conductors electrically coupling theplurality of terminals to the plurality of electrodes; and an anchoringelement manipulatable to extend through at least a portion of the paddlebody, the anchoring element having a distal end portion adaptable tobecome a tissue-engaging element when the distal end portion is urgedout of the paddle body.